CROSS-REFERENCE TO RELATED APPLICATIONS PRIORITYThis application claims benefit of U.S. Provisional Patent Application No. 61/005,316, filed on Dec. 4, 2007, entitled NEEDLE GUIDE SYSTEM FOR USE WITH ULTRASOUND TRANSDUCERS TO EFFECT SHALLOW PATH NEEDLE ENTRY, the entirety of which is incorporated herein by reference.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT“Not Applicable”
INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISK“Not Applicable”
BACKGROUND OF THE INVENTIONThis invention relates generally to medical devices and methods of use and more particularly to needle guide devices and methods of use with ultrasound transducers.
It is a common medical practice to use a guide for releasable securement onto an ultrasound transducer to percutaneously guide a needle or some other puncture device to some desired location within the body of a patient. The patent literature includes various devices for such applications, such as those shown in U.S. Pat. Nos. 5,052,396 (Wedel et al.), 5,076,279 (Arenson et al.), 5,623,931 (Wung et al.), 5,758,650 (Miller et al.), 5,941,889 (Cermak), 6,379,307 (Filly et al.), and 7,087,024 (Pruter).
CIVCO Medical Instruments Co. Inc., the assignee of the subject invention through its related company CIVCO Medical Solutions, sells needle guide systems for use with ultrasonic transducers constructed in accordance with the above identified Filly et al. patent. Such systems consist of a custom reusable, non-sterile biopsy bracket or adaptor and a disposable, sterile snap-on needle guide. The bracket is sold under the trademark L17-5 multi-angle bracket and the needle guide is sold under the trademark Infiniti needle guide. The bracket is in the form of a ring-like member arranged to be releasably secured about a portion of the distal periphery of the ultrasound transducer. A flexible plastic, sterile isolating cover is then placed over the adaptor and the transducer to isolate those components from the patient and to provide a sterile field. The needle guide is then releasably secured, e.g., snap-fit to the adaptor, so that a portion of the cover is interposed between it and the adaptor. The needle guide is arranged to enable the physician or other health care provider to guide the needle or some other penetrating device to a desired location within the body of the patient. To that end, the needle guide basically comprises a pair of spaced apart plates. The needle or other puncture device is arranged to be placed between the plates and oriented at any desired angle to the central axis of the transducer so that the needle's tip can be inserted to any desired depth of penetration. The visualization of the positioning of the needle at the desired location is accomplished by the operation of the ultrasound transducer. The snap-fitting of the Infiniti needle guide to the L17-5 bracket is achieved by means of a pair of aligned grooves at the bottom of the bracket, which are arranged to receive respective projections or bosses located on the bottom of the needle guide to enable the upper portion of the needle guide to be pivoted toward an upper portion of the bracket. The upper portion of the needle guide is in the form of an under-cut arcuate recess. The upper portion of the bracket is in the form of an arcuate surface, which is arranged to mate with the undercut recess in the needle guide. A finger projects from the upper portion of the needle guide adjacent the undercut recess to enable the physician to grasp that finger during the pivoting of the needle guide toward the bracket so as to deform the undercut recess slightly, whereupon the curved surface of the bracket can snap-fit into the recess, thereby releasably securing the needle guide to the bracket with the isolating cover interposed therebetween.
While the aforementioned needle guide system of CIVCO Medical Solutions is suitable for its intended purposes, it still leaves something desired from the standpoint of needle or other puncture device guidance. In particular, the CIVCO Medical Solutions needle guide system does not provide a predetermined path for the needle or other puncture member to take, i.e., the needle or other puncture member can be oriented at any angle between the plates of the needle guide. Thus, a need exists for a needle or other puncture device guidance system for use with ultrasound transducers that facilitates precise positioning along at least one predetermined path. The subject invention addresses that need.
BRIEF SUMMARY OF THE INVENTIONIn accordance with one aspect of this invention there is provided a puncture device guide system for use with an ultrasound transducer and a sterile cover to provide predictable trajectories for puncture devices at various depths. The puncture device guide system basically comprising a bracket and a puncture device guide. The bracket is arranged for releasable mounting on the ultrasound transducer, whereupon the sterile cover can be placed over the ultrasound transducer and the bracket mounted thereon. The puncture device guide is arranged to be readily attached, e.g., releasably snap-fit, to the bracket with the sterile cover interposed therebetween. The guide is constructed, e.g., it includes a base portion and a movable member which together form a passageway establishing a predetermined angled path for a receipt of a puncture device to penetrate into the body of a patient to a desired depth. The puncture guide is openable, e.g., the movable portion can be pivoted away from the base portion, to enable the ultrasound transducer with the needle guide system mounted thereon to be removed from the patient, leaving the puncture device in place penetrating into the body of the patient.
In accordance with one exemplary aspect of this invention the bracket includes a lower portion and the guide includes a lower portion. One of the lower portions of the bracket and the guide is in the form of a convex projection and the other of the lower portions of the bracket and the guide is in the form of a concave recess for mating receipt of the convex projection. This feature enables the guide to be pivoted about a pivot axis extending through the mating concave recess and convex projection in a first rotational direction to snap-fit the guide to the bracket.
In accordance with another exemplary aspect of this invention the movable member is biased to normally be in the pivotably closed position thereby establishing the predetermined angled path for a receipt of the puncture device.
In accordance with another exemplary aspect of this invention the system includes plural puncture device guides. Each of those plural guides is constructed to establish a different, respective predetermined angled path for a receipt of the puncture device.
In accordance with another exemplary aspect of this invention, the puncture device guide includes plural predetermined paths for receipt of a needle or other puncture device to establish plural preselected depths of penetration that can be achieved.
In accordance with another exemplary aspect of this invention the bracket is configured to be mounted on the ultrasound transducer so that the guide is located facing a transverse side of the ultrasonic transducer.
In accordance with another aspect of this invention there is provided a method for introducing a puncturing device into the body of a living being utilizing an ultrasound transducer to provide a predictable trajectory for the puncturing device at various depths. The method basically comprises providing a guide system comprising a bracket and a puncture device guide, releasably mounting the bracket on the ultrasound transducer, whereupon a sterile cover can be placed over the ultrasound transducer and the bracket mounted thereon. The method further entails releasably attaching the guide to the bracket with the sterile cover interposed therebetween to establish a predetermined angled path for a receipt of the puncturing device to penetrate into the body of a patient to a desired depth. The guide is openable to enable the ultrasound transducer and the needle guide system to be removed, leaving the puncture device in place penetrating into the body of the patient.
BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGSThe invention will be described in conjunction with the following drawings in which like reference numerals designate like elements and wherein:
FIG. 1 is an exploded isometric view of one exemplary embodiment of a puncture device (e.g., needle) guide system making use of an adaptor and a needle guide which are constructed in accordance with this invention for use with a conventional ultrasound transducer and a sterile cover;
FIG. 2 is a front elevation view of the system shown inFIG. 1;
FIG. 3 is an isometric view of the adaptor shown inFIG. 1;
FIG. 4 is another isometric view of the adaptor shown inFIG. 1;
FIG. 5 is a slightly enlarged isometric view of the adaptor shown inFIG. 1, but with a portion of it, namely, the passageway forming clamp, removed;
FIG. 6 is a slightly enlarged isometric view of the passageway forming clamp of the adaptor shown inFIG. 1;
FIG. 7 is anFIG. 1 is an exploded isometric view of a second exemplary embodiment of a puncture device (e.g., needle) guide system making use of an adaptor and a needle guide which are constructed in accordance with this invention for use with a conventional ultrasound transducer;
FIG. 8 is a front plan view of the needle guide shown inFIG. 7;
FIG. 9 is a rear plan view of the needle guide shown inFIG. 7;
FIG. 10 is an exploded isometric view of the needle guide shown inFIG. 7;
FIG. 11 is an illustration of an ultrasound transducer making use of a transversely mounted needle guide showing an exemplary image of the needle being inserted into an artery;
FIG. 12 is an illustration of an ultrasound transducer making use of a longitudinally mounted needle guide showing the needle being inserted into an artery; and
FIG. 13 is a top plan view of a kit having a plurality of needle guides for use with the adaptor shown inFIGS. 1-6 to establish penetration depths of 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 2.5 cm, 3.0 cm and 3.5 cm.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTIONReferring now to the drawing wherein like reference numbers refer to like parts there is shown at20 inFIG. 1 one exemplary embodiment of a puncture device guidance system for use with an ultrasound transducer constructed in accordance with this invention. Theultrasound transducer10 is shown by the phantom lines inFIG. 1. Before describing the details of the system20 a brief description of theultrasound transducer10 is in order. To that end, theultrasound transducer10 which is shown by the phantom lines is typical of the construction of conventional medical applications and typically has a central axis which is perpendicular to its distal end or patient engaging face. The cross section of the distal end is of a generally rounded rectangular or ovoid shape having a longer or major longitudinal axis and a shorter or minor transverse axis. Placement of a puncture device is typically accomplished by means of some needle guide mounted on one of the longitudinally extending sides of the transducer or on one of the transversely extending sides. In either case the needle or some other puncture device is arranged to brought in at an angle intersecting the transducer's central axis so that the tip of the needle or other puncture device is at a desired depth within the ultrasound transducer's imaging plane. Thus, the ultrasound transducer can provide an image of the field as the needle or puncture device is positioned in the imaging plane.
InFIG. 11 theultrasound transducer10 is illustrated showing a needle guide, like that of the subject invention, mounted “transversely” on the transducer. By “transversely” mounted it is meant that the needle guide is mounted so that the path that the needle takes with respect to the imaging plane intersects the imaging plane, thereby providing a cross section of the needle and the anatomic structure of the patient in which the needle is located, e.g., within an artery. The subject invention, is particularly suited for transverse mounting on the ultrasound transducer, but can also be arranged for longitudinal mounting. A longitudinally mounted needle guide is shown in the illustration ofFIG. 11. As can be seen therein, with such an arrangement the angled path that the needle takes is in the imaging plane of the transducer.
The puncturedevice guidance system20 basically comprises a bracket oradaptor22 and aneedle guide24. Theadaptor22 is an integral unit which is best seen inFIGS. 1,3,4 and5 and basically comprises a ring-like member having a hollow interior space shaped to accommodate the distal end portion of thetransducer10. The adaptor can be fabricated of any suitable material, e.g., molded of any suitable plastic. The ring-like portion of the adaptor is made up of an opposed pair of longitudinally extendingside walls26 and an opposed pair of transversely extendingend walls28, all of which are conjoined to one another. Since there are numerous shaped ultrasound transducers commercially available the shape of the inner surfaces of the side walls and end walls forming the ring-like portion of the adaptor will be configured to accommodate the particular transducer to which it is to be mounted. The adaptor is arranged to be releasably secured to the transducer via either frictional engagement or mechanical means, e.g., mating components of the transducer and adaptor. In either case theadaptor22 is a reusable member that is mounted on thetransducer10. Then a conventional, flexiblesterile cover12, like shown inFIG. 1, is placed over the transducer on which the bracket is mounted.
Theneedle guide24 is a sterile, preferably disposable member, which is arranged to be readily mounted on theadaptor22 with the flexible,sterile cover12 interposed therebetween, so that the needle guide is resistant to accidental disconnection, but can be readily removed (dismounted) when desired. In accordance with a preferred aspect of this invention theneedle guide24 is arranged to be connected to (mounted on) theadaptor22 by means of a snap-fit connection. That connection will now be described. To that end, as can be seen inFIGS. 1-5 one of the longitudinally extendingside walls26 of theadaptor22 includes aprojection30 extending outward from the outer face of that side wall. Achannel32 is provided in the outer surface of theprojection30, with the top portion of the channel forming aconvex surface34 and with the lower portion of the channel being somewhat linear. A pair offlanges36 extends along the sides of thechannel32. The lower end of eachflange36 is in the form of asemi-circular recess38. Each of therecesses38 is arranged to receive a respective boss, to be described later, of theneedle guide24 to pivotably snap-fit the guide member to theadaptor22.
Theneedle guide24 is best seen inFIGS. 1 and 2 and basically comprises a generally wedge shapedbody40 having an undercutrecess42 in the top portion of the front face of thebody40. The undercut recess is of a concave shape to mate with theconvex surface32 on theprojection30 of theadaptor22. The remainder of the front face of the needle guide's wedge shaped body is in the form of alinear surface44 whose width is just slightly less than the width of thechannel34 of the adaptor'sprojection30 so that it can be received within the linear portion of that channel when the needle guide is mounted on the adaptor. The upper portion of theneedle guide body40 is in the form of afinger46. Astop48 projects downward from thefinger46 and forms the margin for the upper end of the undercutrecess42. Two semi-circular rods orbosses50 project outward from the lower portion (the apex) of theneedle guide body40. Thebosses50 are axially aligned with each other.
The mounting of theneedle guide24 onto theadaptor22 after thecover12 has been placed over the transducer is accomplished as follows. The needle guide is juxtaposed so that its front face is disposed opposite to thechannel32 in the adaptor'sprojection30, with the twobosses50 of the needle guide being located withinrespective recesses38 of theadaptor22. The user then pivots theneedle guide24 towards theadaptor22, using thefinger46 as a pull tab. This causes thestop48 to slide along the upperconvex surface32 of the adaptor until it reaches the end of that surface, whereupon thefinger46 snaps downward, locking thestop48 is place so that theconvex surface34 of the adaptor'sprojection30 is resident within the undercutrecess42 of the guide member.
Theneedle guide24 includes a passageway, to be described later, that establishes a predetermined path through which the needle may be extended to reach a desired depth of penetration. In particular, as will be described in considerable detail later the passageway in the needle guide is arranged to extend at an acute angle to the central axis of the transducer when it is mounted on the adaptor so that the intersection of the angled needle path with the central longitudinal axis of the transducer will be at the desired depth of penetration. That depth of penetration may be any desired depth. In accordance with one preferred embodiment of this invention plural needle guides may be provided, each establishing a different respective angular path, for use with a single adaptor to create different depths of penetration. For example,FIG. 13 shows a kit of plural needle guides24A,24B,24C,24D,24E,24F and24G for producing a series of depths of penetration, e.g., 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 2.5 cm, 3.0 cm and 3.5 cm, respectively. The needle guides24A,24B,24C,24D,24E,24F and24G are preferable molded as aunit200 of any suitable plastic material and are provided in that form for use with anadaptor22. When any particular needle guide is selected for use all that is required is to break it away from the other needle guides via the various breakaway joints202. For example, if the physician wishes to have a needle penetration of 1.5 cm, e.g., to place the needle into an artery, theneedle guide24C would be selected and broken off from the remaining needle guides.Needle guide24C is then be mounted on the adaptor in the manner as described above to establish a guide path taking the needle to a depth of penetration in the transducer's image plane of 1.5 cm.
The angular path established by eachneedle guide24 is in the form of a linear passageway52 (FIG. 4) which extends along the angled outside face of the wedge shapedbody40 of the needle guide. Thepassageway52 is formed by the cooperation of an angularly extending linear groove54 (FIG. 5) in the outside face of the guide member's wedge shaped body and a cooperating groove56 (FIG. 6) in the inner surface ofpivotable member58. Thepivotable member58 is pivotably connected to thebody40 of the guide member by a hinge connection, to be described later. Suffice if for now to state that the pivotable member is biased, by means to be described shortly, so that it is normally in its closed position or orientation like shown inFIGS. 1-4, thereby establishing the predetermined angular path for the needle. The pivotable member is arranged to be moved, i.e., pivoted, to an open orientation to open thelinear passageway52 to enable the transducer and its attachedneedle guide system20 to be removed from the patient, while leaving the needle in place in the patient.
As best seen inFIG. 6 themember58 includes an elongated curved wall portion60 (whose inner surface forms the groove56) and ahandle62. Alinear hinge pin64 projects inward from thehandle62 and extends parallel to thegroove56. Thehinge pin64 is arranged to be pivotably received within aslot66 in the wedge shapedbody40. The hinge pin is held in place within the slot by aretainer68. A small, resilient arcuate shapedtab70 is located on the inner surface of thehandle62 close to thehinge pin64. Thetab70 projects outward from themember58 and is arranged to abut a small ridge72 (FIG. 5) on thebody40 of the guide member to apply biasing force to themember58 to cause it to be in its normally closed orientation.
In order to facilitate the introduction of the needle into the passageway so that it can be guided along the passageway to its desired position within the body of the patient the proximal end of the passageway is flared at74. Theguide member24 is arranged to be able to accommodate needles or other puncture devices of varying gauges. Thus, the guide member can be fabricated so that size of thepassageway52 is will accommodate needles of 18, 21 or 21 gauge. In fact, the passageway can be made to accommodate any size needle or other puncture device. In the exemplary embodiment shown inFIGS. 1-6 the needle guide is arranged for use with an 18 gauge needle. This is indicated by indicia bearing the number “18” appearing on thehandle62 of the needle guide.
Thepivotable member58 of the needle guide is arranged to be opened, i.e., pivoted away from the wedge shapedbody40, by pressing on thehandle62. This action causes theresilient tab70 to bend or flex, whereupon thepivotable member58 pivots outward from its closed orientation to an open orientation (not shown). In the open orientation the entire length ofpassageway52 is accessible laterally. This enables thesystem20 and thetransducer10 on which it is mounted to be removed from the patient leaving the needle in place in the patient, i.e., the combinedtransducer10 andsystem20 can be slid laterally off of the needle leaving the needle undisturbed.
As should be appreciated by those skilled in the art the needle guide attachment geometry as described above provides for very secure attachment without damaging the cover between the bracket and the needle guide. When the guide is attached to the bracket the finger (flexure) portion exerts pressure on the cylindrical bosses maintaining their position in the bracket's locating feature. When the device is used the routine manipulation of the transducer against the patient may exert pressure against the cylindrical bosses into the locating feature thus making the fit of the guide more secure. The flexure feature allows the guide to be attached and removed without friction between the bracket and the guide which is the most common cause of cover damage during guide attachment.
The secure fit of the as achieved by the subject is of considerable importance in transverse entry procedures, where the guide may extend beyond the bracket and be dislodged during routine manipulation of the transducer against the patient.
InFIGS. 7-10 there is shown another embodiment of a puncturedevice guide system100 constructed in accordance with this invention. Thesystem100 is similar in many respects tosystem20, except that itsguide member124 is arranged to provide plural predetermined paths, each establishing a different depth of penetration, whereas with thesystem20 only a single depth of penetration can be effected by any givenguide member24. Thesystem100 basically comprises an adaptor orbracket122 on which theguide member124 is pivotably snap-fit. Theadaptor122 is similar in construction to theadaptor22 in that it includes plural walls which conjoin to form a ring-like member for frictional or mechanical mounting on the distal end portion of the ultrasound transducer. The adaptor includes aprojection130 constructed similarly toprojection30 of theadaptor22. Thus, the common structural element of theprojection130 will be given the same reference numbers as theprojection30 of theadaptor22. Moreover, the details of the construction and operation of theprojection130 will not be reiterated in the interest of brevity. Theguide member124 is similar in construction to theguide member24 insofar as its pivotable snap-fitting mounting on theadaptor122 is concerned. Thus, the common structural elements of the means for snap connecting theguide member124 to theadaptor122 will be given the same reference numbers as the corresponding means for snap connecting theguide member24 to theadaptor22 and the description of the operation for snap connecting theguide member124 to theadaptor122 will be omitted in the interest of brevity.
The means of theguide member124 for establishing the plural angled paths for the needle or other puncture devices will now be described. To that end as shown inFIG. 7, theguide member124 includes a wedge shapedbody140 having plural elongated, linear grooves orslots142,144,146 and148. Since theslots142,144,146 and148 are open, theguide member124 includes associated component in the form ofpivotable cover plates150,152,154 and156, respectively, which are arranged to be pivoted to a closed position to seal the length of those slots, leaving only the distal and proximal ends of the slots open. Thus, when the cover plates are in their closed position, not shown, they cooperate with their associated slots to form the respective enclosed needle guiding passageways of theguide124.
As best seen inFIG. 10 each of the fourcover plates150,152,154 and156 includes a pair of mountingpins158 projecting perpendicularly from its rear surface. Thepins158 extend througharcuate slots160 in the wedge shapedbody140 for fixed securement inrespective apertures162 in apivot plate164. The pivot plate is disposed on the opposite face of theguide member body140 than thecovers150,152,154 and156 so that theguide member body140 is interposed between the cover plates and thepivot plate164. The pivot plate includes anarm166 which flexes as a spring when connected to theguide member body140 between a pair of projecting stops168. The pivot plate includes a handle170 (FIGS. 9 and 10) to enable the user to readily pivot the pivot plate between thestops168. The pivot plate is arranged to be pivoted outward, i.e., in a direction toward theoutside face172 of theguide member body140 to cause thecover plates150,152,154 and156 secured to the pivot plate to also pivot in that direction, thereby causing them to enclose their associated slots. This action forms four, enclosed needle guide passageways for guiding a needle or other puncture device through it. In particular, the user can insert the needle or other puncture device into and through the desired passageway to percutaneously introduce the needle or other puncture device into the patient's body to the depth of penetration as established by the angularity of the selected passageway.
In the exemplary embodiment shown, theslot142 extends at an acute to the front face of the wedge shapedbody140 to establish a depth of penetration of 2.5 cm, theslot144 extends at an acute to the front face of the wedge shapedbody140 to establish a depth of penetration of 1.5 cm, theslot146 extends at an acute to the front face of the wedge shapedbody140 to establish a depth of penetration of 1.0 cm and theslot148 extends at an acute to the front face of the wedge shapedbody140 to establish a depth of penetration of 0.5 cm. As best seen inFIG. 8 the proximal end or entryway of each of theslots142,144,146 and148 is flared to facilitate the introduction of a needle or other puncture device therein.
In order to remove thesystem100 and thetransducer10 on which it is mounted from the patient while leaving the needle or other puncture device in place undisturbed, all that is required is to pivot the pivot plate away from theouter face170, thereby causing the associated pivot plates to pivot to the open position, i.e., a position laterally of their associated slots as shown inFIGS. 7 and 8. Once the slots are open the combinedtransducer10 andsystem100 can be slid laterally off of the needle leaving the needle undisturbed.
While the invention has been described in detail and with reference to specific embodiments thereof, it will be apparent to one skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope thereof.